ZepZelCa TM ( Lurbinectedin ) : First Approval in EEUU ... The Australian Therapeutic Goods Administration, Are Collabora on The Review of ZepZelCa Under The Project Orbis Initiative .

*.- Australia ( TGA ) Has Granted Provisional Designation for New Drug Lurbinectedin based on Encouraging Phase 2 Results and High Unmet Medical Need

*.- ZepZelCa TM To Be Considered Under the 'Project Orbis' Initiative, Which has Been Designed to Allow Collaboration Between the FDA and Select Internacional Regulators, Including the TGA .

*.- ZepZelCa TM Currently Available to Patients in Australia and Singapore Vía a Named Co-pay Patient Access Program .

Anthony Markham / Published: 20 August 2020

Abstract

The Oncogenic Transcription Inhibitor Lurbinectedin (ZEPZELCA™) is Being Developed by PharmaMar as a Treatment for Various Cáncers.

The Drug has Been Granted Orphan Drug Status for the Treatment of Small CELL Lung cancer (SCLC) by Regulatory Authorities in Múltiple Countries Worldwide and was Approved in the USA in June 2020 for the Treatment of Adult Patients with Metastatic SCLC with disease Progression on or After Platinum-based Chemotherapy.

The US FDA and Internacional Regulators, Including the Australian Therapeutic Goods Administration, are Collaborating on the Review of Lurbinectedin under the Project Orbis Initiative.

Clinical Investigation in Other Solid Cáncers is Ongoing. This Article Summarizes the Milestones in the Development of Lurbinectedin Leading to This First Approval for the Treatment of Metastatic SCLC.

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